Efficacy and Safety of HILOTERM® Device for the Prevention of Peripheral Neuropathy

Launched by EUROPEAN INSTITUTE OF ONCOLOGY · May 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a device called Hilotherm® that cools the hands and feet to see if it can help prevent a painful condition called peripheral neuropathy (PN) that can occur after treatment with a chemotherapy drug called Taxol for breast cancer. Many women who receive Taxol experience symptoms of PN, such as tingling, numbness, or pain in their hands and feet, which can last for years and affect their quality of life. The goal of this study is to find out if using the Hilotherm® device can reduce the severity of these symptoms and how well patients tolerate the treatment.

To participate in this trial, women must be over 18 years old and have been diagnosed with certain types of breast cancer that require treatment with Taxol. They should not have any serious health issues that would interfere with the study, and they should not have a history of certain medical conditions, like severe neuropathy or specific autoimmune diseases. Participants will receive the Hilotherm® treatment during their chemotherapy sessions and will be monitored for effects on their neuropathy symptoms and overall well-being. This trial is not yet recruiting participants, but it aims to provide important information on how to improve the quality of life for women undergoing chemotherapy for breast cancer.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women \> 18 years of age
• • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
• • Radically operated infiltrating breast cancer, pT1-T3, pN0-2, M0
• • Candidate to adjuvant chemotherapy that includes weekly paclitaxel 80 mg/m2 intravenous for 12 weeks \[either following anthracyclines and/or in association with trastuzumab\]
• • Negative pregnancy test at baseline (in fertile women)
• • Willing and able to sign informed consent for protocol treatment
• Exclusion Criteria:
• • Evidence of metastatic disease (M1)
• • pT4 and/or pN3
• • Previous or concomitant malignancy of any other type
• • Previous treatment with chemotherapy, hormonal therapy or an investigational drug for any type of malignancy
• • Plans to use a chemotherapy regimen other than those specified in the inclusion criteria
• • Any serious concurrent infection or any clinically significant medical illness (in particular clinically significant liver disease, clinically significant renal dysfunction, clinically significant cardiovascular disease, uncontrolled infections) which would jeopardize the ability of the patient to complete the planned therapy and follow-up
• • Pre-existing motor or sensory neuropathy of any grade, for any reason
• • Participation in any other clinical investigation or exposure to other investigational agents, drugs, device or procedure that may cause PN
• • History of Raynaud phenomenon, either primary or secondary to autoimmune or connective tissue diseases such as systemic lupus erythematous, scleroderma, Buerger disease, Sjögren syndrome, rheumatoid arthritis, occlusive vascular disease, such as atherosclerosis, polymyositis, cold agglutinin disease or cryoglobulinemia, thyroid disorders, pulmonary hypertension
• • Cold urticaria / cold contact urticaria
• • Severe arterial disease
• • Trophic tissue lesions
• • Diabetes mellitus
• • Alcohol abuse
• • History of severe allergic, anaphylactic, or other hypersensitivity reactions to the components of Hilotherm Chemo care device
• • Simultaneous use of Dignicap system to prevent hair loss from chemotherapy